Chart: Cymbalta Clinical Development For Fibromyalgia
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Cymbalta Clinical Development For Fibromyalgia
| Cymbalta Clinical Development For Fibromyalgia | ||
| Date | Action | |
| IND Chronology (#38,838) | ||
| 10/17/2002 | End-of-Phase II meeting regarding primary and secondary endpoints | |
| 7/28/2004 | End-of-Phase II meeting | |
| 8/3/2004 | Cymbalta initial approval for major depressive disorder (NDA #21-427) | |
| 6/23/2006 | FDA says that 3-month, instead of 6-month, trials will be needed for "pain of fibromyalgia" | |
| 4/13/2007 | Pre-NDA meeting | |
| 5/16/2007 | Teleconference with all fibromyalgia sponsors regarding changes in FDA recommendations | |
| NDA Chronology (#22-148) | ||
| 8/14/2007 | NDA submission | |
| 6/4/2008 | Letter sent to sponsor requesting stronger hepatotoxicity language in labeling | |
| 6/10/2008 | Revised label submitted; Lilly also commits to study efficacy of lower doses of Cymbalta | |
| 6/13/2008 | Approval (one day ahead of user fee goal date) | |
| 10/23/2008 | EMEA's CHMP adopts a negative opinion on duloxetine's European fibromyalgia application | |